title: Recruitment of high risk women for HIV prevention trials: baseline HIV prevalence and sexual behavior in the CAPRISA 004 tenofovir gel trial.
abstract: BACKGROUND
  Young women in sub-Saharan Africa bear a disproportionate burden of HIV infection compared to men but have limited options to reduce their HIV risk. Microbicides could fill an important HIV prevention gap for sexually active women who are unable to successfully negotiate mutual monogamy or condom use.
  
  
  OBJECTIVE
  This paper describes the baseline sample characteristics in the CAPRISA 004 trial which assessed the safety and effectiveness of the vaginal microbicide, 1% tenofovir gel for HIV prevention in South Africa.
  
  
  METHODS
  This analysis assessed the baseline demographic, clinical and sexual behavior data of women screened and enrolled into the trial. The characteristics were summarized using descriptive summary measures; expressed as means and percent for categorical variables.
  
  
  RESULTS
  HIV prevalence at screening was 25.8% [95% Confidence Interval (CI):23.9-27.7). Of the 889 eligibly enrolled women who contributed follow-up data, rural participants recruited from a family planning (FP) clinic were younger, more likely to be living apart from their regular partner, reported lower coital frequency, had lower condom use (p < 0.001). In contrast, urban participants recruited from a sexually transmitted disease (STD) clinic reported higher numbers of lifetime sexual partners, new partners in the last 30 days and receiving money in exchange for sex (p < 0.001).
  
  
  CONCLUSIONS
  The populations selected provide suitable diverse target groups for HIV prevention intervention studies.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT 00441298.
authors.affiliation: Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Quarraisha Abdool
authors.initials: QA
authors.lastname: Karim
authors.forename: Ayesha Bm
authors.initials: AB
authors.lastname: Kharsany
authors.forename: Janet A
authors.initials: JA
authors.lastname: Frohlich
authors.forename: Cheryl
authors.initials: C
authors.lastname: Baxter
authors.forename: Nonhlanhla
authors.initials: N
authors.lastname: Yende
authors.forename: Leila E
authors.initials: LE
authors.lastname: Mansoor
authors.forename: Koleka P
authors.initials: KP
authors.lastname: Mlisana
authors.forename: Silvia
authors.initials: S
authors.lastname: Maarschalk
authors.forename: Natasha
authors.initials: N
authors.lastname: Arulappan
authors.forename: Anneke
authors.initials: A
authors.lastname: Grobler
authors.forename: Sengeziwe
authors.initials: S
authors.lastname: Sibeko
authors.forename: Zaheen
authors.initials: Z
authors.lastname: Omar
authors.forename: Tanuja N
authors.initials: TN
authors.lastname: Gengiah
authors.forename: Mukelisiwe
authors.initials: M
authors.lastname: Mlotshwa
authors.forename: Natasha
authors.initials: N
authors.lastname: Samsunder
authors.forename: Salim S Abdool
authors.initials: SS
authors.lastname: Karim
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D005260:Female; D015658:HIV Infections / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D063065:Organophosphonates / Q000008:administration & dosage*; D018579:Patient Selection; D015995:Prevalence; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage*; D018570:Risk Assessment; D012307:Risk Factors; D012424:Rural Population; D012737:Sex Factors; D012725:Sexual Behavior; D013019:South Africa / Q000453:epidemiology; D000068698:Tenofovir; D016896:Treatment Outcome; D014505:Urban Population; D014622:Vaginal Creams, Foams, and Jellies; D016387:Women's Health; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D018894:Reverse Transcriptase Inhibitors; D014622:Vaginal Creams, Foams, and Jellies; D000068698:Tenofovir; D000225:Adenine